- J&J Family of Companies (Raritan, NJ)
- …actions, eg Risk Management, Quality Engineering, Supply Chain, Quality Systems, Compliance , and Regulatory Affairs. + Identify and pursue design control system ... of medical device regulations, standards, and regulatory bodies, eg FDA (Food and Drug Administration), ISO (International Organization for Standardization,… more
- United Therapeutics (Trenton, NJ)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... with vendors and partners to ensure the highest level of quality and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC… more
- Integra LifeSciences (Plainsboro, NJ)
- …set new standards of care. The **Quality Assurance Engineer II** will provide Quality compliance support on all aspects of the Plainsboro, NJ CMC Quality System. The ... that the development, manufacture and distribution of medical products is in compliance with corporate policies, US Food and Drug Administration regulations, ISO… more
- Cardinal Health (Trenton, NJ)
- …a driven and skilled attorney with expertise in healthcare regulatory compliance , including third party billing and reimbursement. The Assistant General Counsel ... colleagues across the AHS order entry and revenue cycle management team, Compliance , the Enterprise Privacy Office, and other internal teams to identify and… more
- Cardinal Health (Trenton, NJ)
- …We also provide customers the support they need in regulatory compliance , reimbursement, continuing education, information management and other crucial areas, so ... investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, including… more
- Fujifilm (Trenton, NJ)
- …diagnosed per year, number of hepatologists). + Adheres to company and compliance guidelines, policies, and procedures. + Effective communication within FUJIFILM IVD ... organization of sales, quality and compliance issues. + Utilization of the IVD reporting systems...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Fujifilm (Trenton, NJ)
- …process changes to improve efficiency and customer satisfaction. + Ensure compliance with all applicable requirements of the company's quality management system. ... HCUS's future business activities. + Adheres to the Company's quality and regulatory compliance requirements and ensures that all job duties inherent in the position… more
- Bristol Myers Squibb (Summit, NJ)
- …and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real-time review of manufacturing ... complete tasks, improve processes, and resolve issues. + Ensure manufacturing compliance with applicable procedures and batch records. + Identify non-conformances to… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets. + Ensures own work ... + BA/BS with 10+ years' relevant experience. + Significant regulatory, quality, compliance or related experience in the biopharma industry. + Proven track record… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …teams of needed updates/changes **Additional responsibilities:** + Represent R&D Compliance in professional and industry organizations. **Knowledge, skills, & ... abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding...to evaluate complex issues and meet deadlines to ensure compliance , as well as business timelines to accomplish company… more